Tag: Type 1

It will bring you up to speed (as quickly as 2500 words can), giving you the information regarding what the Juvenile Diabetes Cure Alliance thinks are the most likely “practical cures” for people with Type 1 diabetes and why their petition demanding JDRF and ADA to commit 30% of donations to “cure research” isn’t doing anything to help the diabetes community except cause deep fractures amongst us.

Part One covered the transplantation “practical cures” that JDCA believes we should all support with the intent to have these cures available by 2025.

Part Two below covers the devices and the immune system manipulation options they highlight.

Quick Recap

The Juvenile Diabetes Care Alliance states that they want a “practical cure” by 2025. JDCA’s Four categories of a “practical cure”:

Islet cell transplantation

A device that mimics the pancreas

Glucose-responsive insulin (“smart insulin”) ***Please note that none of the potential practical cures are of this type.***

Modification of the immune system (blocking, balancing, and/or retraining)

Every year, JDCA issues a report that tells potential donors which “practical cures” are more likely to pull ahead. Here are the 2014 “Potential Practical Cure Solutions,” found in the JDCA State of the Cure report. (2015 hasn’t been published yet, but expect it in the fall as in previous years).

For each, I will provide you the basic info into what it is, where this is in terms of “potential” release into the community and who is funding it.

JDCA’s 2014 Potential Practical Cure Solutions (Part 2)

Device

Bionic Pancreas (iLet)

Boston University

– Boston, MA

What it is:

Engineers from Boston University have developed a bionic pancreas system that uses continuous glucose monitoring along with subcutaneous delivery of both rapid-acting insulin (to lower blood glucose) and glucagon (to raise blood glucose) as directed by a computer algorithm. The bionic pancreas automatically makes a new decision about insulin and glucagon dosing every five minutes; that’s 288 decisions per day, 7 days per week, 365 days per year. (Artificialpancreas.org)

Where it is in the pipeline of “practical cure”:

According to Clinical Trials.gov, Phase III clinical trials will begin soon, with an estimated completion date of August, 2016. 80 participants will be in this trial. All clinical trials to this date have had favorable results.

If the pipeline is followed, commercialization is to be expected by 2018. The major issues will be funding and the FDA approval of stable glucagon provided by Xeris Pharmaceuticals.

Who is funding this “practical cure”?

Drs. Damiano and Russell do not work for a privately funded company. They work for universities. Funding is obtained through NIH grants and generous donations from private donors. JDRF did fund a portion of this research.

There is currently no investment funding for future commercial agreement. Funding is being obtained through donations made through Boston University and Massachusetts General Hospital, private grants, and potentially NIH.

This is one “potential cure” that is fueled by direct donations from the general public.

A Phase II clinical trial which will last five years is being launched.

In the phase I clinical trial, which was published in the August 8, 2012, issue of PLOS Medicine, two injections of BCG spaced four weeks apart led to temporary elimination of diabetes-causing T cells and provided evidence of a small, transient return of insulin secretion. The phase II clinical study will include more frequent dosing over a longer time period to determine the potential of repeat BCG vaccination to ameliorate the autoimmune state and improve clinical parameters such as HbA1c, a marker of average blood sugar control. (Eureka Alert)

Earliest results will be in 2020. Please also be aware that a Phase III Clinical Trial must be conducted after successful results are shown, which can delay commercialization by several years if the Phase II Clinical Trial results show promise.

TOL-3021

Tolerion, Inc.

-Portola Valley, CA

Unlike conventional vaccines, which act to stimulate the immune system, the reverse vaccine TOL-3021 is designed to selectively suppress specific elements of the immune system that are inappropriately activated in type 1 diabetes. TOL-3021 contains an engineered DNA plasmid that expresses proinsulin, which is associated with the autoimmune-caused destruction characterizing type 1 diabetes.(Tolerion website)

These promising Phase 2 data indicate that TOL-3021 may stop the destruction of pancreatic beta cells and improve the long-term outlook for patients with type 1 diabetes, even in adults with long-established disease. Based on these results, we are eager to test TOL-3021 in a larger trial with longer dosing beyond 12 weeks, and to assess whether it might slow or stop disease progression entirely in younger patients when administered before large numbers of beta calls have been destroyed.

There are caveats with the trial. For one, the vaccine must be studied in more humans and is years away from being considered for Food and Drug Administration approval. What’s more, in the study, the vaccine’s benefits tailed off a few weeks after its 12-week dosing schedule was stopped.

I have yet to find another announcement regarding a Phase III clinical trial or anything regarding this “practical cure” since 2013.

Who is funding this “practical cure”?

Dr. Lawrence Steinman, the Stanford researcher who, along with other researchers involved with this project, founded Tolerion. Here’s what he had to say regarding funding:

I can’t give enough praise to Bayhill’s investors, the JDRF (formerly the Juvenile Diabetes Research Foundation) and well-known VCs on Sand Hill Road and the Bay Area.

Rights to the reverse vaccine technology and associated product pipeline have been licensed to Tolerion by Stanford University.

There is no public donation funding being requested.

Cyclosporine Omeprazole/Lansoprazole

Perle Bioscience

-Charleston, NC

What it is:

Cyclosporine is a well-known immunosuppressant given as an anti-rejection medication after organ transplantation and for treatment of RA (rheumatoid arthritis) or psoriasis.

Lansoprazole is a proton-pump inhibitor. You might know it by its brand name: Prevacid.Omeprazole is also a proton-pump inhibitor. (Brand name: Prilosec.) It decreases the amount of acid in the stomach and is commonly used in treating heartburn and GERD (reflux).

PRL001

PRL001 consists of the combination of two previously approved therapeutic agents, each yielding their specific response on the body. In Vivo animal studies, the first product inside of PRL001 causes the regeneration of the patients own insulin producing pancreatic beta cells to start growing again. The second part of PRL001 lowers the body ability from re-attacking the newly formed insulin producing cells to essentially put the pancreas back to how it was functioning prior to diabetes. Both agents are taken orally and no injections are needed for this product. Perle Bioscience, Inc. holds the issued and pending US and IPC patents (see below for patents) for the new use of these agents in treating diabetes. PRL001 is starting multi-center Phase 3 human trials in early 2015.

PRL002

PRL002 is a novel peptide developed by Perle Bioscience, Inc., where in current in vitro and in vivo studies, is showing signs of high levels of regeneration of insulin producing pancreatic cells. PRL002 is made up of our novel Beta Regeneration Agent for Diabetes (BRAD) peptides. Currently PRL002 is in animal trials with the hope to have an IND application to the FDA in early 2016. Our hope is that PRL002 will be used for both type 1 and type 2 diabetes. Please sign up for our newsletter to stay up to date on our progress (signup from the bottom of any page).

There is no mention of the Phase III clinical trial for individuals with “existing Type 1 diabetes” on Perle Bioscience’s website.

Perle is a privately held company, so no investments can be made here as of yet.

Tianhe Stem Cell Biotechnologies

Stem Cell Educator Therapy

-China

What it is:

“Stem Cell Educator therapy” is the innovative technology developed by Dr. Yong Zhao that uses stem cells drawn from human cord blood to targets autoimmune diseases. Currently, Tianhe is focusing on the application of Stem Cell Educator therapy in diabetes. Our clinical data provide powerful evidence that Stem Cell Educator therapy can balance the immune system and lead to the regeneration of islet beta cells and improve metabolic control in long-standing diabetic subjects. This groundbreaking technology is taking steps towards the ultimate cure of diabetes and revolutionizing the treatment of other autoimmune-related diseases.(Tianhe website.)

Where it is in the pipeline of “practical cure”:

Clinical Trials.gov gives this information: Stem Cell Educator Therapy in Type 1 Diabetes was last updated in November, 2013 and is still stating that it is recruiting participants in China and Spain. Expected completion was September, 2014.

The Chinese government, according to the sponsorship information provided on Clinical Trials.gov. The Tianhe website is looking for investors, stating this as an enticement:

A huge marketing opportunity due to the global prevalence of diabetes: For instance, the total number of Americans living with diabetes will increase by 64% in 2025. Annual Medicare cost will increase by 72%, with $514 billion/year (72nd ADA report).

There is no request from the general public for donations.

Previous JDCA “Practical Cures”

JDCA has published three reports, talking about the “cure” and which projects they believe fall under the guidelines. I’ve focused on the 2014 report (which is the latest), but what about 2013? 2012? (They began in 2011.)

2013

In 2013, here’s what they said were practical cures paths, because they were in human trials:

Sitagliptin/Lansoprazole (Phase II) Note: collaborator listed on ClinicalTrials.gov is JDRF. Status listed now as “The recruitment status of this study is unknown because the information has not been verified recently. )

ATG/GCSF – This Phase II clinical trial is no longer recruiting patients but is active (meaning they got enough participants). The work is still ongoing, but if you read the criteria, it was modified to say that the participants must have been diagnosed between 1 and 2 years before the start of the study, taking out the possibility for those with long-standing Type 1 to participate. The trial is called: Reversing Type 1 Diabetes After it is Established and is being run by University of Florida with grants from the Helmsley Charitable Trust and Genzyme.

My Scorecard for 2014 Practical Cures

Based on what JDCA says are “practical cures” and what I’ve researched, here is the likelihood that they will become commercially available by JDCA’s 2025 “deadline.”

Transplantation

VIACYTE – Phase I/II clinical trial right now. Estimated commercialization date of this product if Phase I/II is successful, a Phase III trial is conducted and successful and proceeds to FDA approval? Unlikely by 2025.

DIABECELL – Phase I/IIa completed. No Phase III clinical trials listed in ClinicalTrials.gov. Estimated commercialization date of this product if there is a Phase III trial and it proceeds to FDA approval? Unlikely by 2025.

STEM CELL EDUCATOR THERAPY – Phase II clinical trial listed in 2013 and still recruiting. Estimated commercialization date of this product if Phase I/II is successful, a Phase III trial is conducted and successful and proceeds to FDA approval? Unlikely by 2025.

Conclusion to this LONG Part 2…

What one organization thinks is a cure isn’t always a cure to you. It’s easy for JDCA call out an organization for not doing enough for what they think is “cure research.”

It’s much more difficult to do so when you realize that everyone has a different (and in JDCA’s reports, showing an ever changing) idea of what a “practical cure” would mean.

What is practical in 2012, 2013, and 2014 may not be practical in 2015. JDCA kept mentioning DRI’s BioHub, but never put it on the top list of their “practical cures,” but yesterday’s announcement that the first human subject to be implanted with the BioHub is off insulin. (Time will tell is this is successful in the long-term, but JDCA didn’t consider this a donation priority.)

What about “smart insulin?” What about the other closed loop AP trials? What about…. something we haven’t thought of yet? We don’t know what the young researchers in five years will present to major diabetes organizations (or the general public). Seed money comes from these large diabetes non-profits to new researchers who seek out grants to get them off the ground. What happens to these researchers if they don’t get the seed money?

Nothing. Literally.

JDCA is cherry-picking (and finger pointing, but to what end remains to be seen). It’s their right and I’ve learned a lot about the different avenues to a “practical cure. ” (Hat tip to JDCA for sending me down the rabbit hole. I’m certainly better educated for it.)

We are ALL cherry-picking. It’s our right. But do it by doing the research and making smart, educated choices.

We are all in this together, despite differences in opinions about what a cure entails, who is going to provide it, and who should fund it. And most importantly, who speaks for you. (Here’s a hint… it’s not me or JDCA.) It’s my hope that you learned something about “cure research” and where YOU can get your information about cure pipelines so you can speak for yourself.

Like this:

Over the past few weeks, I’ve been seeing infographics produced by the Juvenile Diabetes Care Alliance (JDCA) regarding “cure research” and major diabetes organizations.

The infographic is not flattering, and like everything related to statistics, not entirely truthful. (JDCA even admitted in a post on FB that they made some “judgment calls” in their numbers.)

At first, I ignored the repeated posting in Facebook groups of how JDRF and ADA have not done enough to find a cure for us, but after a while, the bashing became nothing but a “I hate these organizations and I’ll never donate to them again. How dare they take our money and do nothing.”

I spoke up and reminded individuals in those groups that there are MANY ways to use the donations raised through walks and rides and other fundraising opportunities, but that ALL of the donations were being used to help people with diabetes, whether it be for research or for support. (And I also reminded them that there was a marked absence in this infographic of where one should be donating…)

My opinion voiced, I went on my merry way, living my life with diabetes, until I got an unsolicited email yesterday from someone claiming to be an employee of JDCA, asking me to promote, on my blog and through social media channels, their petition to the major diabetes non-profits, DEMANDING that JDRF and ADA use 30% of all donations for “practical cure research” through my blog.

Thank you for the invitation, JDCA. I’m going to pass.

Instead, I’m going to take my blog and use it took peek into what your privately funded non-profit, founded by the CEO of Activision Blizzard Entertainment (and a parent of a child diagnosed with Type 1 diabetes at the age of 2) wants us to focus on, rather than telling us what JDRF and ADA isn’t doing.

As I began writing this and hit 2500 words, I realized that this needs to be digested in more than one sitting, so I’m splitting this into 2 blog posts. (Mostly, because no one except masochists read 2500 words of my blog at a time and because I WANT YOU TO READ ALL OF THIS IMPORTANT AND UNBIASED INFORMATION.) Today, I’m covering just the Transplantation “practical cures” and you’ll get the others tomorrow in Part 2.

Juvenile Diabetes Research Alliance

According to a WSJ article, Mr. Kelly’s family foundation, the Brian and Joelle Kelly Family Foundation, has donated $1 million dollars (as of the 2013 article stated) to JDCA. The goal of JDCA is to help donors “become educated about charities that are focused on a “practical cure” for Type 1 diabetes.

Note: Hey, I have no problem with the fact they have spent $1 million dollars to create a “watchdog” organization. They could have spent it on a boat or a house or funding one of their “practical cure” projects. If you’ve got money, you also have the right to spend it as you see fit. I also believe in watchdog organizations, as long as you provide factual, correct, public-facing information.

“Practical Cure”

The Juvenile Diabetes Care Alliance states that they want a “practical cure” by 2025. For their definition, a “practical cure” meets the following four criteria:

Minimal Monitoring (checking BGs less than once per week and a A1C between 5-7%)

Being able to sleep without worrying (about hypoglycemia or hyperglycemia)

Being able to eat whatever one wants without having to evaluate carbohydrate intake

Minimal side effects, understanding that some insignificant side effects are “acceptable”

Sounds reasonable, right? I’m all for that, because that elusive “don’t have to do anything ever again, it’s like magic and you don’t have to think about diabetes for the rest of your life” is a dream.

It then begs the question: What is JDCA’s idea of a practical cure?

JDCA’s Four Ideas of a “practical cure”:

Islet cell transplantation

A device that mimics the pancreas

Glucose-responsive insulin (“smart insulin”)

Modification of the immune system (blocking, balancing, and/or retraining)

Again, sounds reasonable, right? Some of these practical cures are beginning to look like they may not make the 2025 timeframe cut-off, but you never know, right?

Every year, JDCA issues a report that tells potential donors which “practical cures” are more likely to pull ahead. Here are the 2014 “Potential Practical Cure Solutions,” found in the JDCA State of the Cure report. (2015 hasn’t been published yet, but expect it in the fall as in previous years) – and I’m going to show you where the funding is coming from.

JDCA’s 2014 Potential Practical Cure Solutions

These solutions are broken down by type of “practical cure” and gives you the basic info into what it is, where this is in terms of “potential” release into the community and who is funding it. (For my own personal curiosity, I have delved deeper into some than others.) As a reminder, Part 1 is ONLY transplantation. Part 2 is the rest of the “practical cures.”

Transplantation

VC-01

(ViaCyte – a privately held, for profit company)

-San Diego, CA

ViaCyte’s innovative product is based on the differentiation of stem cells into pancreatic beta cell precursors (PEC-01™), with subcutaneous implantation in a retrievable and immune-protective encapsulation medical device (Encaptra® drug delivery system). Once implanted, the precursor cells mature into endocrine cells that secrete insulin and other hormones in a regulated manner to control blood glucose levels. ViaCyte’s goal is a product that can free patients with type 1 and type 2 diabetes from long-term insulin dependence.

Where it is in the pipeline of “practical cure”:

ViaCyte, Inc. announced in July 2014 that it had filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence. This first-in-human trial will evaluate the safety and efficacy of ViaCyte’s VC-01™ product candidate, a stem cell-derived, encapsulated cell replacement therapy. ( Viacyte’s website)

They are in Phase I/II clinical trials at two locations, with an expected trial end date of August, 2017 with an estimated enrollment of 40 participants. Note: According to Wikipedia, “The percentage of Phase II trials that proceed to Phase III, as of 2008, is 18%.” Estimated commercialization date is unknown, but safe to say more than five years off.

The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01™ combination product that ViaCyte is developing for type 1 diabetes. This right will continue through the initial evaluation of clinical efficacy of VC-01. ViaCyte received $20 million from Janssen and Johnson & Johnson Development Corporation (JJDC). The payment included a rights fee and a note convertible into equity at a later date. JJDC has been a long-standing investor in ViaCyte.

DIABECELL

(Living Cell Technologies – a multinational for-profit in a joint venture with DOL)

– New Zealand, Japan

What it is:

DIABECELL is an insulin-producing cell product derived from pigs for the treatment of type 1 diabetes. These islet cells are self-regulating and efficiently secrete insulin in the patient’s body.

The treatment involves introducing encapsulated pig cells into the patient’s abdomen in a simple laparoscopic procedure. Living Cell Technologies’ unique proprietary encapsulation technology prevents the islet cells from being attacked by the patient’s immune system. This allows the use of cell therapies without the need for co-treatment with drugs that suppress the immune system, which often have negative side effects.

Where it is in the pipeline of “practical cure”:

To date, a total of 46 patients have taken part in clinical trials of DIABECELL. The goals of these trials have been to find the optimal dose required for DIABECELL and to obtain early indication of its effectiveness in controlling type I diabetes. These trials showed that DIABECELL has the potential to significantly reduce the number of unaware hypoglycaemic events that people living with Type I diabetes experience, whilst also reducing their insulin dose and not experiencing a rise in HbA1c.

Phase I/IIa safety study (Russia) – Two out of the eight trial patients discontinued insulin injections for up to 32 weeks. (The assumption being that after 32 weeks, they resumed insulin injections.)

According to Seeking Alpha, an investment media company: “Mostly, the results are more modest involving decreased insulin injections and significant reduction in unaware hypoglycemic events.”

There are currently no clinical trials offered through Clinical Trials.gov (a global trial locator).

Who is funding this “practical cure”?

LCT is an Australian for-profit company with headquarters and operations located in New Zealand. They have a joint venture with Diatranz Otsuka Limited (DOL). In June of 2015, DOL announced:

Diatranz Otsuka Limited (DOL), is to concentrate its research and development activities in supporting the development of DIABECELL® in the United States. As a consequence, research, development and manufacturing of DIABECELL in New Zealand will cease and there will be a reduction of staff at DOL’s headquarters in Auckland.

Otsuka Pharmaceutical Factory, Inc. (OPF), DOL’s 50% shareholder, is full sponsor and funder of the US program, operating under and exclusive license from DOL for US development and commercialisation of DIABECELL. Since securing the license, OPF has made positive progress, establishing a solid partnership framework for the US development.

DOL’s know-how, research to date and clinical experience in pig islet transplantation will be actively combined with OPF’s global drug development expertise and these partnerships to further strengthen and expedite the US development program.

This alignment of DOL’s expertise with the US program is part of DOL’s previously announced commitment to focus on the US development and FDA approval of DIABECELL. Once registered in the US, DOL retains a royalty free right to commercialise the FDA approved product in the rest of the world.

And of greater interest, Seeking Alpha says of DOL:

Otsuka is a formidable Japanese company with an established presence for its products in the US. Most notably its Abilify antipsychotic drug (shared with Bristol-Myers Squibb (NYSE:BMY)) generated $6.5 billion in US sales in 2013 (a top 10 US drug). To show it is no shrinking violet, Otsuka is involved in a fight to keep out generic versions of Abilify by suing the FDA!

None of these companies are non-profits and expressly state that they will sell and commercialize this product. They have not requested funding for cure research from the public.

ßAir Bio-Artifical Pancreas

Beta-O2 Technologies

– Tel Aviv, Israel

What it is:

The ßAir Bio-artificial Pancreas is a macrocapsule that contains islets of Langerhans, cells from pancreatic regions of the body that contain hormone-producing beta-cells. The macrocapsule provides a fully isolated environment for the islets to thrive. The islets in the bio-artificial pancreas replace the function of the endocrine part of the pancreas; i.e., the sensing of the level of glucose in the blood and the regulation of the production of insulin and glucagon as needed.

ßAir has the potential to ‘normalize’ the lives of people living today with type 1 diabetes. How? Of greatest importance, the ßAir bio-artificial pancreas eliminates the need for frequent glucose testing and insulin injections. Immunosuppressive therapy, which has many side effects, is also not required.

Note: as the ßAir device contains ‘living’ cells, the patient must commit to keeping them healthy. Once every 24 hours, the patient needs to refill the air in the device using a replenishing device which includes a dedicated injector. This guarantees that the cells will have the requisite oxygen supply to thrive and perform their insulin and glucagon production role.

Replenishing the device is performed by injecting oxygen into one of two ports implanted under the skin. The replenishing device is very user friendly, requires minimal technical skills for operation, and has very few possibilities for incorrect operation. The replenishing procedure takes just about two minutes. An alarm will trigger if something has gone wrong. (Beta O2 Website)

My Conclusion from Part 1:

For all the talk about JDRF not helping to fund a “practical cure,” I’m here to show you that JDRF is helping. Perhaps not to the extent that JDCA deems acceptable.

Who is JDCA to determine how much is acceptable?

Their “survey” of 1,000 donors in 2014, conducted by a third party (but where did they get their donor responses? Ask yourself that as they didn’t publicly state it in their report) claims that 88% of donors want their donations to go to “cure research.” The questions were targeted to invoke “cure” responses.

And before you jump on me saying that I’m a shill for JDRF (or ADA, who hasn’t been mentioned by me yet)… be very aware of this fact:

I donate to one of the “practical cures” that JDCA touts.

I’ve asked others for their help in funding this “practical cure.” I also donate to other diabetes non-profits, some big and some small, because I know (from my own thirty-two years of T1 diabetes) that while

I would sell everything I own to have a cure, crawl across a minefield strewn with broken glass to not have this horrible disease haunt me…

in the meantime, we need support and research for the complications from this disease.

Every time a parent complains about a school issue in the US, every time a child gets a T1 peer or mentor, every time a teenager goes to a summer camp where diabetes is the norm, every time a family member views their loved one’s BG graph on a device from miles away… those donations matter, too.

Conclusion: DO. YOUR. OWN. RESEARCH.

More information is coming in Part 2, including JDCA’s practical cure solutions: devices (1) and immune system modifications(4).

Don’t be surprised. Or disappointed.

I was told in 1983 there would be a cure in five years. I’ve waited this long. We’ll all be waiting a little longer.

* I have chosen not to link to JDCA’s website. On purpose. They’re easy to Google if you want to see what I did. I’ve linked to the deep dive stuff.

Like this:

Clinical trials are the only way that we are going to get better treatments, better devices, and better…cures.

Here are seven noteworthy diabetes clinical trials recruiting now that you might want to look into and see if you (or anyone you know) might be eligible to volunteer.

Click on the titles of each trial to get more info straight from the ClinicalTrials.gov website.

(Remember… some clinical trials may have you take a placebo in lieu of the investigational drug. Some clinical trials may require extra visits, invasive testing, and travel. You need to think about what the benefits and risks are for trial participation. That being said… nothing ventured, nothing gained.)

The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained.

Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas.

If you’re interested and meet the criteria (and the location, as the trial is being conducted in Boston and requires weekly injections for the first year… don’t know if you can do this at home…), you should send an email to: diabetestrial@partners.org

Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control.

If you are on multiple daily injections, this might be a great opportunity to participate in a really interesting study if you are willing to wear a continuous glucose monitor (CGM) and possibly a pump. Check out the inclusion/exclusion criteria and locations, then send an email or call to either:

The primary objective of the study is to determine whether the routine use of Continuous Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and effective as CGM used as an adjunct to BGM.

This study will determine if we can actually make treatment decisions based on our CGM alone when we feel it is accurate, not verifying it with a finger-stick blood glucose check.

This. Is. Huge.

Why? Because one of the reasons why Medicare, Medicaid, and some insurance companies refuse to pay for a continuous glucose monitor, claiming it’s just an adjunct to a blood glucose meter and we still have to check to make treatment decisions. (And we know better, don’t we?) This trial has a lot of inclusion and exclusion criteria, but seriously… if you can do this, you will help the entire T1 diabetes community get access to this device.

This is to trial the Abbot Libre system, which is a sensor with “flash monitoring” for individuals with Type 2 diabetes. How cool is that? They currently need participants in the following locations: San Diego, Detroit, Kansas City, MO and Pearland, TX. If you meet the criteria, shoot Dr. Karinka an email for more info and get enrolled.

If you are a newly diagnosed (within the last two years) adult (over 18), you can participate in a Phase 1 clinical trial for a biological drug, examining safety issues. Again, look at the criteria and locations, then if you are interested, call:

Pfizer CT.gov Call Center

1-800-718-1021

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038764

This is a Medtronic study for their next step in the artificial pancreas technology pathway. (And hello… “Enlite 3 sensor!”)

All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

The more patients willing to participate in artificial pancreas technology trials, the faster this technology will become available! Take a look at the locations and criteria and if you’re able to do this trial, contact:

There are so many studies out there that need our help. We help ourselves AND all people with diabetes. Do what you can. If you can’t participate, share this post with someone who might be able to volunteer.

Like this:

Desperately Seeking Diabetes Nanny.

Cajoling me to check my blood sugars, even though I wear a CGM and am sometimes lulled into a sense of false security

Showing me that sometimes, a CGM can be wrong but that it’s OK

Forcing me to sit and calculate how many carbohydrates will going into my mouth, factoring in the fat and protein content with that wild card of how much insulin I currently have on board and how much exercise I might be doing in the near future (or how much I did in the distant past) and if it’s that time of the month or if I’m not feeling well or… at least telling me that it’s OK that the amount of insulin I take is based on too many factors to nail it every time

Waking me up when that alarm goes off, signifying a low blood glucose level in the middle of the night, because I might be sleeping peacefully and soundly (Because who needs an uninterrupted night’s sleep? Not this woman.) and stuffing me with glucose when I tell you that I’m perfectly fine

But wait… there’s more!

Ensuring that I have, in my possession, before I leave the house: my meter, my strips, emergency glucose that doesn’t taste yucky (Glucolift, FTW), back-up insulin to inject if my pump fails, an extra pump cartridge, an extra infusion set, a snack in case I get caught somewhere and can’t get something to eat

Willing to navigate the labyrinth called the U.S. Healthcare system with its endless medical necessity letters and insurance claims that get kicked back and the multiple phone calls required to get a straight answer about what is covered and what isn’t covered

Patting my hand (or covering my mouth) when someone makes an ignorant comment about diabetes and I have to give the elevator speech about what diabetes is and isn’t, how we get it and how we don’t, and that sugar isn’t our enemy (our pancreases are)

Pushing me to stand up and take a stand when I see injustice in the world: lack of access to the drugs, devices, and services that can keep people with diabetes healthy – and alive

Let’s not forget this part of the job!

Holding me tightly when I am drenched in sweat, shaking, and unable to wait that proposed 15 minutes before ingesting another 15 or 30 grams of carbohydrates after a gut-wrenching low blood sugar – or when I am lethargic, thirsty, and bitchy after a high blood sugar that came out of nowhere

Reminding me that complications can happen to everyone with diabetes, no matter how tightly or loosely controlled their management has been and that it doesn’t make me – or anyone else with diabetes – a “bad” person

Lifting my head to look to the horizon for small, but important, advances in diabetes research to inspire me to keep going

Consoling me when I learn of a life lost to diabetes

Understanding that I will never be cured, even if a “cure” is found tomorrow, as the damage done to my body will stay long after diabetes is gone

Keeping me sane when diabetes slows me down

Important aspects of being a diabetes nanny you should know about:

This is a 24/7/365 position.

There are no vacation days, sick leave, retirement plan.

You’ll get on-the-job training, as the manuals don’t seem to cover the day-to-day living with diabetes.

This job has been held by parents, friends, coworkers, spouses, and sometimes, strangers, but they can’t really explain what they did or how they did it. You’ve got to experience it for yourself.

You may not be angry at me (or the world) for having diabetes, although you can be angry with me.

Did I mention that this is an unpaid position and no opportunity to advance?

Like this:

Whether you want to attribute it to Lincoln’s famous speech regarding slavery or a line in the New Testament (Mark 3:25), I’m repeating it for all of us to hear:

“A house divided cannot stand.”

I have diabetes. It’s an insipid disease that slithers into lives, laying waste and fear in its wake. It cannot be compared to other diseases; it’s unfair and pointless. Moments are stolen from all of us who live in the shadow of its open maw, and sometimes not just moments, but the very breath we draw.

It does not matter what permutation of diabetes exists in my body. In every form, regardless of subset, the insufficient supply of insulin damages cells and organs and brains. Depending on the insufficiency, the damage can be rapid or so slow that it’s not noticed until well after the damage is done.

Every person with diabetes is at risk for stroke, heart disease, retinopathy, blindness, kidney disease, neuropathy. Every person.

Every family with diabetes is subjugated to stress, heartache, frustration, and financial burdens. Every family.

The Divided House

I am a member of the diabetes community. Anyone who lives or cares for someone with diabetes is a part of the community. We all want the same end result: long, healthy lives free of the burden of this chronic illness.

Some of the community focuses their time and effort on cures. Others on technology. Emotional support. Financial issues. There are many avenues this community travels down together. All are worthy when the goal is to help make our lives better.

But this community, this house I love, is a house divided.

Over the past few years, as voices amplify with the Internet’s loudspeaker, the rise of separatist factions is coming to bear. Here are the voices from the crowd:

“I’m sick of the public thinking I’m Type 2.”

“Those people could have just not gotten fat and they wouldn’t have gotten Type 2.”

“Type 1s talk about how hard it is, but they don’t realize that Type 2s struggle too.”

“My son did nothing to deserve getting Type 1.”

“I’m thin with Type 2, but people think that it’s lifestyle, not genetics that got me here.”

Who Lives In Our House

29.1 million people have diabetes in the United States.

21.0 million of them are actually diagnosed. The rest (8.1 million, because that’s easy math for me to do) is undiagnosed. People walking around with slightly elevated blood glucose levels… enough to do long-term damage.

3.0 million of those diagnosed with diabetes are Type 1. (Only about 10 percent of the total diabetes population.)

The dollar cost of diabetes, direct and indirect for 2012, which is the latest stat, is $245 billion. (The indirect part is work loss, disability, and death.)

The numbers are fuzzy because we don’t look at the big picture. What does this house look like? Is it a duplex with no way to help each other if someone needs support? Is it an apartment building with tiny boxes for parents of T1s, T2s, adult T1s, undiagnosed/pre-diabetes T2s, Medicare recipients, uninsured, and T2 kids all coexisting and trying to get landlord’s attention?

Our House is Getting Crowded

Every thirty seconds, we get a new member in our house. Every thirty seconds, someone in the United States is diagnosed with diabetes. We need a stable house with a firm foundation, because we need more room. The rate of diabetes is not decreasing; it’s increasing.

Without strong, unifying voices, we’re going to be fighting over who gets to use the remote control or who hogs the bathroom in the morning.

Step outside of the house and go stand on the sidewalk. How do you think our house looks like to a passerby on the street?

Is the exterior a hodgepodge of different colors, because we couldn’t decide?

Are windows boarded up because a particular group doesn’t need the sunlight shining on them?

Do we have an inviting path to greet everyone who knocks?

Is there a beautiful, intricate melody with different voices singing the same song, but allowing each group an opportunity to solo… but the chorus is the same? Or does the world hear cacophony? Or worse… nothing at all because we’re all just whispering different things?

I do not want a diabetes house divided.

I want a diabetes home.

Home, Sweet Home

How can you help make our house a home?

Educate the public about diabetes: the differences AND the similarities between the different types. (Get educated yourself by reviewing the statistics and the research and the information that many major diabetes organizations provide to help explain.)

Let your policymakers know that it doesn’t matter what type of diabetes we have; we ALL matter when it comes to funding and public policy. There are bills being introduced on the Hill and in some states that can help – or hurt – people with diabetes. Find out what you can do. Even if you’re a Type 2, you can lend your support and your voice to CGM Medicare bill.

Ask people to describe their diabetes when you’re having conversations. If you (or your child) has Type 1 diabetes, learn from a person (children get Type 2 as well, although it’s not as prevalent) with Type 2 about what they do every day to live well with diabetes.

Focus on what is important: life WITH diabetes, not matter what Type, deserves attention and respect. In fact, we all as humans deserve attention and respect. Find the common ground and even if you don’t have much common ground, there is a piece that we can all build from…

Help build our community.

Help build our home.

Help make a home for everyone impacted with diabetes and let the world know that we are united.